Routine Patient Care Research Articles

Myelofibrosis Is Associated with Poor Cardiovascular Outcomes after Heart Failure Hospitalization

Background: Myeloproliferative neoplasms (MPN), including essential thrombocythemia (ET), polycythemia vera (PV), and myelofibrosis (MF), are at high risk of cardiovascular (CV) disease including heart failure (HF). Prior studies have suggested patients with MPN are at increased risk of HF. Among patients with MPN, those with MF have the most aggressive disease with significantly shortened survival. However, data on CV outcomes among patients with MF are sparse. Therefore, we examined CV outcomes among patients with MPN hospitalized for HF. Methods: This was a retrospective cohort analysis of the National Readmission Database (NRD) of adult patients with a primary diagnosis of HF from 2017 and 2018 with a history of MPN (N = 4632), which were identified using ICD-10 codes. The primary outcome was 90-day unplanned CV-related readmission (readmission for HF, arterial thrombotic event [ATE], or venous thromboembolism [VTE]). Secondary outcomes were index hospitalization death and 90-day any-cause unplanned readmission. Propensity scores (PS) for estimating probability of MF were calculated using non-parsimonious multivariable logistic regression that included all baseline patient characteristics examined. PS weighting (PSW) was utilized to adjust for potential confounders. Patients with MF were compared with patients with ET or PV and standardized mean difference (SMD) was calculated for variables before and after PSW. Imbalances between groups were significant if SMD for a given covariable was ≥ 0.10. Hazard ratios (HR) were estimated for 90-day readmission outcomes using Cox proportional hazards regression and odds ratio (OR) for estimating index hospitalization death were calculated using logistic regression. Results: A total of 3748 patients with ET or PV (2639 ET, 1109 PV) and 884 with MF were included. Prior to PSW, patients with MF were older (mean age 77.7 vs 74.3 years), more likely to have anemia (53.8% vs 47.2%) and less likely to be female (44.9% vs 56.1%), have systolic HF (39.9% vs 46.1%), and cardiogenic shock (1.6% vs 3.4%) compared with ET/PV, Table. After PSW, baseline characteristics were well balanced between groups. After PSW, MF was associated with increased risk of 90-day CV readmission (HR 1.18, 95% CI 1.08 - 1.30), index hospitalization death (OR 1.67, 95% CI 1.38 - 2.01), and 90-day any-cause readmission (HR 1.26, 95% CI 1.17 - 1.35). Additionally, MF was associated with increased risk of 90-day HF readmission (HR 1.24, 95% CI 1.12 - 1.38) but not ATE (HR 0.62, 95% CI 0.47 - 0.81) or VTE-readmission (HR 0.72, 95% CI 0.43 - 1.19), Figure. Conclusions: Patients with MPN admitted with HF have high rates of 90-day CV-related and any-cause readmissions. MF was associated with higher risk of 90-day CV-related, HF, and any-cause readmission compared with patients with ET or PV. Patients with MF had higher risk of index HF hospitalization mortality compared with ET or PV. More investigation is needed in order to identify risk factors for adverse CV outcomes in patients with MPNs with HF, particularly those with MF. Although preventing thrombotic complications and managing CV risk are part of routine care for ET and PV patients, this study highlights the importance of incorporating CV risk management in MF patients.

Optimizing Albuminuria Assessment in Patients with Sickle Cell Disease: Insights from the Sikamic Study

Background Patients with sickle cell disease (SCD) are at increased risk of developing renal complications, making early detection and management of these issues critical. Albuminuria has been identified as a relevant biomarker associated with chronic kidney disease (CKD) progression in SCD, as demonstrated in several studies (Gonzalez et al., 2017; Guasch et al., 2018). Quantification of albuminuria is typically performed using the urine albumin-to-creatinine ratio (ACR). However, this measurement is not without its challenges, as variability in results can occur due to several factors, including analytical method, varying sampling conditions, and biological and medical factors such as physical activity, diurnal changes, diet, and hydration, which require the collection of multiple consecutive first morning samples. Studies have shown that the use of ACR from first morning urine samples provides results comparable to the gold standard 24-hour urine collection, with improved precision and less intra-individual variability than random urine samples typically collected during clinic visits (Witte 2009, Jermendy 2001, Lambers 2008). Collecting more urine samples generally improves precision and statistical power, but Kröpelin et al (2025) showed that collecting more than three consecutive urine samples does not significantly improve precision. Material and method The ongoing SIKAMIC study is a phase IIb, international (France and Africa), double-blind, randomized, placebo-controlled trial. The study aims to determine the effect of hydroxycarbamide on albuminuria level after 6 months of treatment in SCD adult patients. Here, we analyzed the variability of ACR in all patients pre-selected for the study. Microalbuminuria is commonly considered the first clinical indicator of glomerular damage in SCD. As per the KDIGO (Kidney Disease: Improving Global Outcomes), microalbuminuria is characterized by an ACR ranging from 3 to 30 mg/mmol, while macroalbuminuria refers to an ACR greater than 30 mg/mmol. For SIKAMIC study, patients with an ACR above 3 mg/mmol and below 100 mg/mmol were included. ACR was measured in first morning urine samples over three consecutive days. Patients were instructed to collect these samples at home, which were either collected by a hospital courier or brought to the hospital/laboratory by the patient for analysis. Estimated glomerular filtration rate (eGFR) was calculated using the CKD EPI formula without ethnic criteria. Means and standard deviations of the three measurements were calculated per patient, and a reproducibility test was performed using Mixed Effect Model and Bland Altman analyses (Graphpad Prism 9). Results Out of the initial 179 patients pre-selected for the study (59 from France and 120 from Africa) 99 patients (34 in France and 65 in Africa) met the inclusion criteria and were enrolled in the SIKAMIC study. Pre-selected patients from Africa were younger than patients from France with a mean age of 28.3 years and 33.8 years respectively (p<0.001). However, the mean ACR did not differ between groups (11.8 vs 12.7 mg/mmol; p=0.8) as observed for the mean eGFR value (123 vs 120.9; p=0.75). Additionally, the sex ratio was similar between groups (0.62 vs 0.67). For all patients, the mean ACR was 14.6, 17.3 and 15.6 mg/mmol on days 1, 2 and 3, respectively, with no significant difference (p=0.43; Figure 1 : A). The mean standard deviation of ACR between day 1, 2 and 3 was 6.8 mg/mmol, suggesting good consistency and reproducibility of the ACR measurements over the three days. Bland-Altman plots are shown in Figure 1 for the total population (n=161; 1B), microalbuminuric (1C; n=86) and macroalbuminuric (1D; n=11) patients, illustrating the agreement of ACR measurements within these subgroups. Conclusion : The SIKAMIC study contributes valuable insights into the evaluation of albuminuria in SCD patients. The reproducibility of the ACR appears to be sufficient to allow satisfactory monitoring on a single morning measurement in SCD routine care, both in Africa and Europe population of SCD patients.

Predicting Molecular Alterations from Blast Morphology of Acute Myeloid Leukemia Bone Marrow Aspirate Smears Using Machine Learning

Introduction Acute Myeloid Leukemia (AML) has enormous molecular and cytogenetic heterogeneity. Evaluation of bone marrow morphology is essential in the diagnosis of AML, however, it requires significant training and there is wide inter-observer variability. Genomic testing has been progressively relied on for AML classification, ultimately helping to dictate prognosis and guide clinical management. However, genomic testing, if performed, can be subject to prolonged turnaround times and lacks clinical penetration in low-resource settings. To overcome these challenges, we aimed to evaluate the feasibility of predicting clinically relevant genomic alterations from bone marrow cell morphology using a machine learning approach. Methods We scanned 799 Wright-stained bone marrow aspirate smear slides, made for routine patient care, for subjects diagnosed with AML. These subjects were linked to clinical data, including pertinent cytogenetic/molecular alterations and subclassified as cases with mutated Nucleophosmin 1 ( NPM1), those with TP53 mutations and those with myelodysplastic-related changes (AML-MRC). Whole slide images were screened for containing spicules and blasts, and were analyzed to detect 180 million cells (blasts and non-blasts) excluding hemodilute and particle regions. We developed a multi-instance model to predict patient molecular subtype by repeatedly sampling 512 cells from each slide and using these to train a classifier that weights cells with morphology relevant to subtype. We also trained a model to predict NPM1 and TP53 mutations independently, as well as other frequent variants reported to impact blast morphology. Results Performance in predicting NPM1/TP53/AML-MRC subtype was moderate (0.80 AUROC). Performance of the single-gene model varied, with NPM1 having the highest performance (0.85 AUROC) followed by IDH (0.80 AUROC), FLT3 (0.79 AUROC) and TP53 (0.62 AUROC). Conclusions This study provides promising preliminary results for prediction of genetic alterations in AML in a large-scale single-institution dataset. Interestingly, this method did not rely on the classification of individual cells, avoiding the need for manually collecting annotations to train a blast cell classifier. Future work will evaluate the morphology of cells attended by the multi-instance model, and explore the value of enriching sampled cells with blasts using cell classification methods.

Epidemiology of vancomycin-resistant enterococci in the United Arab Emirates: a retrospective analysis of 12 years of national AMR surveillance data.

Enterococci are usually low pathogenic, but can cause invasive disease under certain circumstances, including urinary tract infections, bacteremia, endocarditis, and meningitis, and are associated with peritonitis and intra-abdominal abscesses. Increasing resistance of enterococci to glycopeptides and fluoroquinolones, and high-level resistance to aminoglycosides is a concern. National antimicrobial resistance (AMR) surveillance data for enterococci from the Middle East and North Africa (MENA) and the Gulf region is scarce. A retrospective 12-year analysis of N = 37,909 non-duplicate diagnostic Enterococcus spp. isolates from the United Arab Emirates (UAE) was conducted. Data was generated by routine patient care during 2010-2021, collected by trained personnel and reported by participating surveillance sites to the UAE National AMR Surveillance program. Data analysis was conducted with WHONET. Enterococcus faecalis was the most commonly reported species (81.5%), followed by Enterococcus faecium (8.5%), and other enterococci species (4.8%). Phenotypically vancomycin-resistant enterococci (VRE) were found in 1.8% of Enterococcus spp. isolates. Prevalence of VRE (%VRE) was highest for E. faecium (8.1%), followed by E. faecalis (0.9%). A significant level of resistance to glycopeptides (%VRE) for these two species has been observed in the majority of observed years [E. faecalis (0-2.2%), 2010: 0%, 2021: 0.6%] and E. faecium (0-14.2%, 2010: 0%, 2021: 5.8%). Resistance to fluoroquinolones was between 17 and 29% (E. faecalis) and was higher for E. faecium (between 42 and 83%). VRE were associated with higher patient mortality (RR: 2.97), admission to intensive care units (RR: 2.25), and increased length of stay (six excess inpatient days per VRE case), as compared to vancomycin-susceptible Enterococcus spp. Published data on Enterococcus infections, in particular VRE-infections, in the UAE and MENA region is scarce. Our data demonstrates that VRE-enterococci are relatively rare in the UAE, however showing an increasing resistance trend for several clinically important antibiotic classes, causing a concern for the treatment of serious infections caused by enterococci. This study also demonstrates that VRE were associated with higher mortality, increased intensive care unit admission rates, and longer hospitalization, thus poorer clinical outcome and higher associated costs in the UAE. We recommend the expansion of current surveillance techniques (e.g., local VRE screening), stricter infection prevention and control strategies, and better stewardship interventions. Further studies on the molecular epidemiology of enterococci are needed.

Clinical factors associated with illness perception, worry and mental health in sclerosing cholangitis: A single centre prospective study

BackgroundA reduced quality of life and symptoms of depression and anxiety are reported in patients with primary sclerosing cholangitis (PSC), however specific risk factors and the effect of sclerosing cholangitis (SC) with autoimmune features are not known. ObjectiveTo integrate mental wellbeing assessment into routine clinical care for patients with SC, and evaluate factors associated with measures relating to quality of life, illness perception and mental health. MethodsA prospective study of adult non-transplant patients with SC attending the outpatient clinic over a 1 year period. Self-reported questionnaires were sent to patients electronically prior to clinic to assess worry, illness perception, depression and anxiety. Demographic and clinical information was collected. ResultsQuestionnaires were completed in 52/130 (40 %) patients with SC who attended clinic. Worry related to quality of life, mental and physical health, and future health were common. There was no difference in overall worry or illness perception in patients treated with ursodeoxycholic acid; whilst patients with PSC had a higher illness perception (P = 0.04) than those with SC and autoimmune features. Both worry (P = 0.047) and illness perception (P = 0.01) were higher in patients with elevated alkaline phosphatase, whilst there was no difference in patients with and without cirrhosis. There were high screening test scores for both depression (21.1 %) and anxiety (9.6 %), with no association with patient factors. ConclusionsWe integrated an electronic questionnaire for completion prior to clinic for patients with SC with good uptake. We identified a high prevalence of patient worries and symptoms of depression and anxiety, which may be more common in PSC with elevated alkaline phosphatase and without autoimmune features. We recommend the adoption of similar tools into routine clinical practice for patients with SC.

Evaluation of feasibility phase of adaptive version of locally made bubble continuous positive airway pressure oxygen therapy for the treatment of COVID-19 positive and negative adults with severe pneumonia and hypoxaemia.

Bubble continuous positive airway pressure (bCPAP) oxygen therapy has been shown to be safe and effective in treating children with severe pneumonia and hypoxaemia in Bangladesh. Due to lack of adequate non-invasive ventilatory support during coronavirus disease 2019 (COVID-19) crisis, we aimed to evaluate whether bCPAP was safe and feasible when adapted for use in adults with similar indications. Adults (18-64 years) with severe pneumonia and moderate hypoxaemia (80 to <90% oxygen saturation (SpO2) in room air) were provided bCPAP via nasal cannula at a flow rate of 10 litres per minute (l/min) oxygen at 10 centimetres (cm) H2O pressure, in two tertiary hospitals in Dhaka, Bangladesh. Qualitative interviews and focus group discussions, using a descriptive phenomenological approach, were performed with patients and staff (n = 39) prior to and after the introduction (n = 12 and n = 27 respectively) to understand the operational challenges to the introduction of bCPAP. We enrolled 30 adults (median age 52, interquartile range (IQR) 40-60 years) with severe pneumonia and hypoxaemia and/or acute respiratory distress syndrome (ARDS) irrespective of coronavirus disease 2019 (COVID-19) test results to receive bCPAP. At baseline mean SpO2 on room air was 87% (±2) which increased to 98% (±2), after initiation of bCPAP. The mean duration of bCPAP oxygen therapy was 14.4 ± 24.8 hours. There were no adverse events of note, and no treatment failure or deaths. Operational challenges to the clinical introduction of bCPAP were lack of functioning pulse oximeters, difficult nasal interface fixation among those wearing nose pin, occasional auto bubbling or lack of bubbling in water-filled plastic bottle, lack of holder for water-filled plastic bottle, rapid turnover of trained clinicians at the hospitals, and limited routine care of patients by hospital clinicians particularly after official hours. If the tertiary hospitals in Bangladesh are supplied with well-functioning good quality pulse oximeters and enhanced training of the doctors and nurses on proper use of adapted version of bCPAP, in treating adults with severe pneumonia and hypoxaemia with or without ARDS, the bCPAP was found to be safe, well tolerated and not associated with treatment failure across all study participants. These observations increase the confidence level of the investigators to consider a future efficacy trial of adaptive bCPAP oxygen therapy compared to WHO standard low flow oxygen therapy in such patients. s Although bCPAP oxygen therapy was found to be safe and feasible in this pilot study, several challenges were identified that need to be taken into account when planning a definitive clinical trial.

Effectiveness and safety of direct oral anticoagulation vs. warfarin in frail patients with atrial fibrillation.

Although frail patients with atrial fibrillation (AF) carry a high risk of stroke and treatment-related bleeding complications, evidence for the safety and effectiveness of anticoagulation remains sparse. This study investigated the effectiveness and safety of direct oral anticoagulant (DOAC) vs. warfarin in frail AF patients. Nationwide registry-based cohort study including 32 048 anticoagulation naïve frail patients (median age 80 years, 53% female) with incident AF during 2012-20. Frailty was assessed using the hospital frailty risk score. To address baseline confounding, we applied inverse probability of treatment weighting (IPTW) and marginal structural models with weighted pooled regression to compute weighted hazard ratios (wHRs) and risk differences for thromboembolism and major bleeding comparing specific DOAC doses with warfarin. After AF diagnosis, 6747 (21.1%) initiated warfarin, 17 076 (50.3%) initiated standard-dose DOAC, and 9179 (28.6%) initiated reduced-dose DOAC. Comparative effectiveness analyses in the IPTW pseudo-populations revealed similar thromboembolism risk between standard-dose DOAC and warfarin [wHR 0.95, 95% confidence interval (CI) 0.80-1.13] and between reduced-dose DOAC and warfarin (wHR 0.97, 95% CI 0.77-1.23). The 1-year thromboembolic event-free survival difference was -0.2% for DOAC, regardless of dosing, vs. warfarin. Major bleeding risk was significantly lower with standard-dose DOAC (wHR 0.69, 95% CI 0.59-0.87) and reduced-dose DOAC (wHR 0.67, 95% CI 0.55-0.81) vs. warfarin. The 1-year bleeding risk difference with DOAC ranged from -1.3% to -3.0%. Our findings indicate comparable thromboembolism risk and significantly lower bleeding risk with both standard and reduced DOAC regimens compared with warfarin in frail AF patients in routine care.

The impact of prior authorization review on orthopaedic subspecialty care: a prospective multicenter analysis

BackgroundPrior authorization review (PAR), in the United States, is a process that was initially intended to focus on hospital admissions and costly high-acuity care. Over time, payors have broadened the scope of PAR to include imaging studies, prescriptions, and routine treatment. The potential detrimental effect of PAR on healthcare has recently been brought into the limelight, but its impact on orthopedic subspecialty care remains unclear. This study investigated the denial rate, the duration of care delay, and the administrative burden of PAR on orthopedic subspecialty care. MethodsA prospective, multicenter study was performed analyzing the PAR process. Orthopedic shoulder and/or sports subspecialty practices from six states monitored payor-mandated PAR during the course of providing routine patient care. The insurance carrier (traditional Medicare, managed Medicare, Medicaid, commercial, worker’s compensation or government payor (i.e. Tricare, VA), location of service, rate of approval/ denial, time to approval/ denial, and administrative time required to complete process were all recorded and evaluated. ResultsOf 1,065 total PAR requests, we found a 1.5% (16/1065) overall denial rate for advanced imaging or surgery when recommended by an orthopedic subspecialist. Commercial and Medicaid insurance resulted in a small but statistically significantly higher rate of denial compared to traditional Medicare, managed Medicare, worker’s compensation, or governmental insurance (p < 0.001). The average administrative time spent on a single PAR was 19.5 minutes, and patients waited an average of 2.2 days to receive initial approval. Managed Medicare, commercial insurance, worker’s compensation, and Medicaid required approximately 3 to 4 times more administrative time to process a PAR than to traditional Medicare or other governmental insurance (p<0.001). After controlling for the payor, we identified a significant difference in approval/denial based on geographic location (p<0.001). An appeal resulted in a relatively low rate of subsequent denial (20%). However, approximately a third of all appeals remained in limbo for 30 days or more after the initial request. ConclusionThis is the largest prospective analysis to date of the impact of PAR on orthopedic subspecialty care in the United States. Nearly all PAR requests are eventually approved when recommended by orthopedic subspecialists, despite requiring significant resource utilization and delaying care. Current PAR practices constitute an unnecessary process that increases administrative burden and negatively impacts access to orthopedic subspecialty care. As healthcare shifts to value-based care, PAR should be called into question, as it does not seem to add value but potentially negatively impacts cost and timeliness of care.

Hyperthyroidism therapy: What can decision support systems already achieve?

AbstractCurrently, only a few theoretical support systems exist for the treatment of hyperthyroidism. They are typically not practically applicable and solely focus on Graves’ disease. The recently developed DigiThy software framework can be used to assist physicians for methimazole dose titration during the treatment of Graves’ disease. In this study, a pool of 60 virtual patients was created to compare physicians’ individual treatment approaches by 8 different physicians and students (including three colleagues, unexperienced with care of Graves’ disease) with the decision support system DigiThy in terms of already defined performance indices. These indices are used to assess the deviation of FT4 from the reference range throughout the treatment. The computer aided treatment algorithms outperformed the usual care approach according to different prespecified criteria for treatment success. Two out of the three unexperienced colleagues improved their treatment success over time, i.e. with more patients treated. In conclusion, our findings suggest that the DigiThy software may be a useful tool for use as a decision support system in routine care of patients with Graves’ disease, while also serving as an effective training tool for the education of physicians. Randomized controlled studies are required before implementation of DigiThy in daily clinical practice.

Assessing Readiness for Transition From Pediatric to Adult Gender Affirming Care

PurposeTransitioning from pediatric to adult care is a critical juncture in the health of adolescents. Little is known about how best to optimize transition to adult care among transgender and nonbinary (TGNB) youth. While the Transition Readiness and Assessment Questionnaire (TRAQ) has been validated in other pediatric populations, it has not been studied in TGNB youth. Our aims were to pilot the use of the TRAQ for TGNB patients, describe transition readiness patterns, and identify factors associated with transition readiness. MethodsThe TRAQ was introduced into routine clinical care for patients and their caregivers in a large, urban pediatric gender program in the spring of 2021. We performed a retrospective chart review comparing TRAQ responses based on demographic and clinical data. ResultsWe collected TRAQs from 153 adolescents (mean age: 19 years [standard deviation 2.36], range: 11–24). The TRAQ demonstrated good internal reliability with a Cronbach alpha of 0.926. Patients scored highest in the TRAQ subdomains of talking with providers and tracking health issues and lowest in the subdomains of managing medications and appointment keeping. Age and presenting to the appointment alone were associated with higher TRAQ scores. DiscussionWe found that the TRAQ is internally reliable in a sample of TGNB youth. Factors associated with higher TRAQ scores and patterns identified in TRAQ score subdomains provide an insight into the needs of TGNB youth preparing to transition to adult gender-affirming care. Future research should focus on tracking transition readiness longitudinally, developing and evaluating interventions to improve transition readiness, and assessing post-transition outcomes.

Significant participation bias and suboptimal cardiovascular risk management in learning healthcare systems due to non-consent

Abstract Background Computer-aided clinical decision support algorithms require continuous adjustments (learning) to account for changes in patient-characteristics, treatment(s), and outcomes, also referred to as a "Learning Healthcare System" (LHS). A LHS’s accuracy depends on adequate reflection of all patients, and participation bias may distort its effectiveness substantially. Therefore, we studied participation bias in a single center cardiovascular cohort study. Methods The cardiovascular cohort was set up as a LHS aiming for guideline-based treatment according to the individual risk profile for all cardiovascular disease patients in routine clinical care. Patients visiting an outpatient clinic for first time evaluation of a cardiovascular disease or risk factor received information on the cardiovascular cohort prior to their visit. During visit, cardiovascular risk management (CVRM) data was collected in the electronic health record (EHR) and informed consent was asked. We studied differences in characteristics between consenting, non-consenting and non-responding patients, and used multivariable logistic regression to identify determinants of non-consent. Multinomial regression was used for exploratory analyses of non-response determinants. A waiver (19/641) was obtained from the institutional review board for this study. Results In total, 2378 patients were consenting, 1907 non-consenting, and 1445 non-responding. In short, non-consent was related to higher cardiovascular risk (e.g., a cardiovascular disease history (OR 1.43, 95%CI 1.23-1.66)) and lower education (OR 0.76, 95%CI 0.60-0.97) than consent (Figure 1). Non-response, in contrast, was associated with higher physical activity (OR 1.04, 95%CI 1.01-1.08) and education level (OR 1.43, 95%CI 1.04-1.98) compared to consent. Non-consent and non-response patients were, respectively, younger and older. Presence of CVRM indicators in the EHR was 5-30% lower in non-consenting and 37-69% lower in non-responding patients compared to consenting patients. Conclusion A traditional informed consent procedure leads to participation bias in a LHS. Furthermore, it affects structured registration of CVRM indicators in the EHR, which is detrimental for the LHS feedback loop, and potentially leads to suboptimal cardiovascular risk management in patients not willing to participate. This study underlines the importance of reassessing the need of a traditional informed consent procedure for the use of routine care data in learning healthcare systems.

Real-World Experience of Using Etelcalcetide for Secondary Hyperparathyroidism in Community-Based Hemodialysis Centers in Singapore.

Introduction Chronic kidney disease-related mineral and bone disorder (CKD-MBD), characterized by abnormalities in calcium, phosphate, and parathyroid hormone metabolism, with impaired bone turnover and extravascular calcification is a known complication of advanced chronic kidney disease (CKD). Secondary hyperparathyroidism (SHPT) develops early in the disease and its prevalence gradually increases with the disease progression, becoming almost universal in patients with end-stage renal disease (ESRD).The treatment for SHPT includessynthetic vitamin D analogs, calcitriol or calcimimetics. Recently, intravenous etelcalcetide was introduced as a second-generation calcimimetic. This article provides the real-world experience of using etelcalcetide in multiethnic Asian patients receiving hemodialysis at community-based hemodialysis centers in Singapore. Methods This study was real-world evidence, generated by a retrospective clinical audit of routine clinical care of hemodialysis patients in community-based centers in Singapore who received etelcalcetide for treating SHPT.The information on the starting and maximum dose of etelcalcetide, duration of treatment on hemodialysis, parathyroid hormone (PTH) levels, dialysate calcium, concomitant medications, and reasons for discontinuation were collected from the medical records. PTH levels were collected at four-, eight-, and twelve-month intervals. Results A total of 148 patients received etelcalcetide during the study period. Ten patients died and twenty discontinued their treatment, with 118 patients remaining on treatment. Demographically, the patients included Chinese, Malay, Indians, and those belonging to other racial groups. The starting dose of etelcalcetide ranged from 2.5 mg once per week to 7.5 mg three times a week. There was a 16.8% reduction (p=<0.001) in intact-PTH after four months of therapy. Target intact-PTH level of less than 60 pmol/L, was reported as 1.4% at baseline, with 22.3% at four months (p<0.001) and 25.9% at eight months (p=0.028). Calcium and phosphate levels were also tracked as part of the safety and efficacy measures of using etelcalcetide. No symptomatic hypocalcemia was noted and phosphate levels were noted to decline significantly. Overall, the calcium-phosphate product reduced at four months (13.2%, p=<0.001) and eight months (12.7%, p<0.05). An analysis of concomitant medication usage, dialysate calcium utilized, and the side effects of etelcalcetide were also recorded. Finally, a brief descriptive analysis of the patient's subjective feedback regarding etelcalcetide was also reported, especially regarding the reduction in pill burden and overall compliance to medications. Conclusion Etelcalcetide is safe and effective for treating SHPT in multi-ethnic Asian hemodialysis patients and can be considered an alternative to oral cinacalcet. Our study showed no side effects, which was one of the key reasons for non-compliance to traditional calcimimetics. A favorable compliance profile with reduced pill burden was noted by using this intravenous calcimimetic.

Frequency of standardized patient-reported outcome measures in routine clinical care of patients with cancer.

342 Background: Patient-reported outcomes (PROs) assess a patient’s self-reported health status, including disease symptoms, treatment experience, functional outcomes, and quality of life. Incorporation of PROs has been linked to improved patient symptom control and increased shared decision making. Standardized PRO measures (PROMs) are becoming more frequent as an endpoint for clinical trials, however their use is less frequent in routine care for patients with cancer. The goal of this study was to assess the utilization of PROMs and identify barriers to their use. Methods: US-licensed oncologists/hematologists convened at one of three live meetings in 2023 to review recent clinical updates. Respondent demographics were collected ahead via an online survey. During the meetings, participants responded to queries on their use and perceptions of PROs and PROMs. Responses were captured via audience response system technology; not all participants answered every question. Pooled data were summarized using descriptive statistics. Results: Of the 146 respondents, 77.4% self-identified as community-setting providers, spent 84.3% of their time seeing patients, saw an average of 19.8 patients/day, and averaged 17.7 years of experience. Respondents found PROs to be most useful in early detection/management of treatment toxicities and symptoms (63.8%) and tailoring of clinical/supportive care (56%). The majority of PROs are typically recorded through informal verbal inquiries, while 18.1% and 10.9% of respondents use validated and non-validated PROMs, respectively. Few respondents (11.3%) administer PROMs to every patient at every visit, while over one-third (38.3%) never administer PROMs. Within the practice, medical assistants and nurses are most likely to be the provider administering PROMs. PROMs are most commonly administered when the patient is in the office and are infrequently administered through other means. Lack of time to administer or review PRO surveys (45.1%), and lack of reimbursement (38.9%) and EMR integration (38.9%) were the most common reported barriers to using PROMs in the respondents’ practices. Conclusions: Despite the majority of respondents finding PROs useful in practice, a minority use formal measures to record PROs. Further, usage is infrequent across patient visits. Lack of time, lack of reimbursement, and logistic barriers are the most common reasons for not using PROMs in routine care. These barriers may be overcome by efforts or guideline changes from regulatory agencies, payors, or clinical guideline organizations. Future work will assess how physicians are using PROMs in treatment selection for their patients with cancer.

Comparative effectiveness of nirmatrelvir/ritonavir versus sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in non-hospitalised high-risk patients during Omicron waves: observational cohort study using the OpenSAFELY platform.

Timely evidence of the comparative effectiveness between COVID-19 therapies in real-world settings is needed to inform clinical care. This study aimed to compare the effectiveness of nirmatrelvir/ritonavir versus sotrovimab and molnupiravir in preventing severe COVID-19 outcomes in non-hospitalised high-risk COVID-19 adult patients during Omicron waves. With the approval of NHS England, we conducted a real-world cohort study using the OpenSAFELY-TPP platform. Patient-level primary care data were obtained from 24 million people in England and were securely linked with data on COVID-19 infection and therapeutics, hospital admission, and death, covering a period where both nirmatrelvir/ritonavir and sotrovimab were first-line treatment options in community settings (February 10, 2022-November 27, 2022). Molnupiravir (third-line option) was used as an exploratory comparator to nirmatrelvir/ritonavir, both of which were antivirals. Cox proportional hazards model stratified by area was used to compare the risk of 28-day COVID-19 related hospitalisation/death across treatment groups. A total of 9026 eligible patients treated with nirmatrelvir/ritonavir (n=5704) and sotrovimab (n=3322) were included in the main analysis. The mean age was 52.7 (SD=14.9) years and 93% (8436/9026) had three or more COVID-19 vaccinations. Within 28 days after treatment initiation, 55/9026 (0.61%) COVID-19 related hospitalisations/deaths were observed (34/5704 [0.60%] treated with nirmatrelvir/ritonavir and 21/3322 [0.63%] with sotrovimab). After adjusting for demographics, high-risk cohort categories, vaccination status, calendar time, body mass index and other comorbidities, we observed no significant difference in outcome risk between nirmatrelvir/ritonavir and sotrovimab users (HR=0.89, 95% CI: 0.48-1.63; P=0.698). Results from propensity score weighted model also showed non-significant difference between treatment groups (HR=0.82, 95% CI: 0.45-1.52; P=0.535). The exploratory analysis comparing nirmatrelvir/ritonavir users with 1041 molnupiravir users (13/1041 [1.25%] COVID-19 related hospitalisations/deaths) showed an association in favour of nirmatrelvir/ritonavir (HR=0.45, 95% CI: 0.22-0.94; P=0.033). In routine care of non-hospitalised high-risk adult patients with COVID-19 in England, no substantial difference in the risk of severe COVID-19 outcomes was observed between those who received nirmatrelvir/ritonavir and sotrovimab between February and November 2022, when Omicron subvariants BA.2, BA.5, or BQ.1 were dominant. UK Research and Innovation, Wellcome Trust, UK Medical Research Council, National Institute for Health and Care Research, and Health Data Research UK.

Utility of telemedicine for providing Obstetrics and Gynecology services during the COVID-19 pandemic—A single center experience from a tertiary care teaching hospital located in South India

BACKGROUND: The COVID-19 pandemic greatly impeded the provision of public healthcare within a healthcare system that was already under considerable strain. Routine patient care services were impacted during that time, leading to the promotion of telemedicine as a means of maintaining uninterrupted healthcare services. Telemedicine involves the utilization of electronic technology and communication to provide health-related information and medical care to individuals who are physically separated from healthcare professionals. MATERIALS AND METHODS: To assess the feasibility of utilizing telemedicine for providing women's health services, we conducted a six-month analysis of data collected from the Department of Obstetrics and Gynecology's teleconsultation application at AIIMS, Mangalagiri. Our objective was to evaluate the practicality of telemedicine in delivering diverse healthcare services to women. Our institution offered two types of telehealth services: a “call-based”approach and an “app-based”approach. We examined several parameters within the data, including the distribution of ages, the geographic locations of teleconsultation registrations, whether the registrations were new or follow-up cases, the various presenting complaints, the recommended treatments, the number of consultations (single or multiple), and whether cases required in-person or hospital visits. Additionally, we also compared patient responses between these two modalities. RESULTS: The “call-based”consultation method was preferred by the majority of our patients (94%). The registered cases included both related to obstetrics and gynecology, with a higher proportion of complaints relating to gynecological issues (82.5%). We were able to make a diagnosis in 77% of cases, while in 20% of cases, additional physical examinations and diagnostic tests were necessary. Follow-up appointments were recommended for 53% of patients. The success rate of consultations for patients seeking obstetrics and gynecology services showed a statistically significant difference (P value &lt; 0.001). The vast majority of patients (99%) expressed high satisfaction with the consultation process. CONCLUSION: During the COVID-19 pandemic, telemedicine proved to be an effective approach in mitigating the overcrowding of hospitals and preventing the spread of infection. Its success suggests that telemedicine can be a viable option for managing elective gynecology matters and low-risk obstetric cases in the future, thereby alleviating the strain on healthcare systems.

The Effect of Music Therapy on Pain, Anxiety, Perceived Stress, and Biochemical Parameters in Hospitals Among Patients with Cancer

Background: Diagnosis of cancer and its long and hard treatment process induce great stress and anxiety in patients. Cancer patients may also suffer from severe pain due to their primary disease, metastases, or the received treatments. However, the patients’ chief physical complaint is the main aspect that physicians pay attention to, and the mental health of these patients is usually neglected. Objectives: This study aimed to predict the effect of music therapy (MT) on pain, perceived stress, anxiety, and biochemical parameters in patients with cancer. Methods: This semi-experimental study was conducted on cancer patients referring to the Oncology Clinic at Amir Hospital in Shiraz (affiliated with Shiraz University of Medical Sciences) from April to September 2016. A total number of sixty cancer patients were recruited using a random sampling method and divided into two groups of control and intervention. Patients in the intervention group listened to light music for at least 20 minutes for 8 weeks (two continuous sessions weekly). After the intervention group, a follow-up test and questionnaires were conducted on both groups. Data were analyzed by SPSS version 21 using the t-test, chi-square test, and paired t-test. Results: The results of this study showed that the control group had no significant difference regarding the McGill Pain Questionnaire (MPQ) (P-value = 0.797), cortisol (P-value = 0.841), and the Perceived Stress Scale (PSS) (P-value = 0.001) variables before and after the study, but it had a significant increase in the Beck Anxiety Inventory (BAI) (P-value = 0.026). Our findings indicated a significant difference in the MPQ, BAI, and cortisol variables in the MT group (P-value ≤ 0.001). In general, the PSS showed no significant difference between the two groups. Conclusions: The results of the present study showed that MT for eight weeks, selected by patients from a list, could significantly reduce patients’ anxiety, pain, and perceived stress. Therefore, we recommend the inclusion of this intervention in the routine care of patients with cancer.

Improvement in medical consultation by using an AI-powered symptom assessment application (SAA)

Abstract Introduction The shortage of healthcare workers affects countries worldwide and primarily affects people in rural areas. Although Romania trains a high number of physicians, the absence of effective retention and motivation policies leads many of them to opt for higher-paying jobs in other countries. As a result, patients experience long travel and wait times. Our study assessed if using an AI-powered SAA, Ada, in a waiting room is feasible for patients, can improve consultation efficiency, and enhance patient-physician communication. Methods This study was conducted in the waiting room of a GP in Cluj-Napoca, Romania, from May to July 2022. Consenting patients completed a symptom assessment while waiting for their consultation. A survey was administered to patients, the study nurse, and physician to gather feedback on their experience. Results The study enrolled 49 patients (29 women, 20 men). Most of the patients found the questions in Ada to be of appropriate length (94%), understandable (90%), and engaging (86%). Patients using Ada felt that they could express all their health issues (79%) and explain their symptoms better to the doctor (84%). They also felt more confident to discuss symptoms that their doctor may have missed (86%) and would use Ada again (84%). Most patients completed the assessment independently (65%). The study physician reported that 70% of patients who used Ada answered questions quickly and asked more questions related to their symptoms. Discussion By providing personalized health information, Ada prepared patients for their consultation, resulting in improved patient engagement and facilitation of clinical conversation. Incorporating a SAA into routine patient care has the potential to enhance the quality of medical care and reduce consultation time, thus, compensating for physician shortages. Further studies to determine the efficacy of integrating SAA with telemedicine can further help tackle the issue of uneven health workforce distribution. Key messages • Patients found Ada, a mobile AI-powered symptom assessment application, easy to use, understandable, and would use it again. The app helped prepare patients for their doctor’s consultation. • Doctors reported increased patient engagement in consultation among users of Ada. These apps can help save time when used by patients in the waiting room and the results are shared with the doctors.

Testing a Model of Care for Patients on Immune Checkpoint Inhibitors Based on Electronic Patient-Reported Outcomes: Protocol for a Randomized Phase II Controlled Trial.

Management of severe symptomatic immune-related adverse events (IrAEs) related to immune checkpoint inhibitors (ICIs) can be facilitated by timely detection. As patients face a heterogeneous set of symptoms outside the clinical setting, remotely monitoring and assessing symptoms by using patient-reported outcomes (PROs) may result in shorter delays between symptom onset and clinician detection. We assess the effect of a model of care for remote patient monitoring and symptom management based on PRO data on the time to detection of symptomatic IrAEs from symptom onset. The secondary objectives are to assess its effects on the time between symptomatic IrAE detection and intervention, IrAE grade (severity), health-related quality of life, self-efficacy, and overall survival at 6 months. For this study, 198 patients with cancer receiving systemic treatment comprising ICIs exclusively will be recruited from 2 Swiss university hospitals. Patients are randomized (1:1) to a digital model of care (intervention) or usual care (control group). Patients are enrolled for 6 months, and they use an electronic app to complete weekly Functional Assessment of Cancer Therapy-General questionnaire and PROMIS (PROs Measurement Information System) Self-Efficacy to Manage Symptoms questionnaires. The intervention patient group completes a standard set of 37 items in a weekly PROs version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire, and active symptoms are reassessed daily for the first 3 months by using a modified 24-hour recall period. Patients can add items from the full PRO-CTCAE item library to their questionnaire. Nurses call patients in the event of new or worsening symptoms and manage them by using a standardized triage algorithm based on the United Kingdom Oncology Nursing Society 24-hour triage tool. This algorithm provides guidance on deciding if patients should receive in-person care, if monitoring should be increased, or if self-management education should be reinforced. The Institut Suisse de Recherche Expérimentale sur le Cancer Foundation and Kaiku Health Ltd funded this study. Active recruitment began since November 2021 and is projected to conclude in November 2023. Trial results are expected to be published in the first quarter of 2024 and will be disseminated through publications submitted at international scientific conferences. This trial is among the first trials to use PRO data to directly influence routine care of patients treated with ICIs and addresses some limitations in previous studies. This trial collects a wider spectrum of self-reported symptom data daily. There are some methodological limitations brought by changes in evolving treatment standards for patients with cancer. This trial's results could entail further academic discussions on the challenges of diagnosing and managing symptoms associated with treatment remotely by providing further insights into the burden symptoms represent to patients and highlight the complexity of care procedures involved in managing symptomatic IrAEs. ClinicalTrials.gov NCT05530187; https://www.clinicaltrials.gov/study/NCT05530187. DERR1-10.2196/48386.

Understanding satisfaction and dissatisfaction of patients with telemedicine during the COVID-19 pandemic: An exploratory qualitative study in primary care.

Due to the COVID-19 pandemic, healthcare organizations had to face challenging circumstances and modify the usual modality of service provision, introducing telehealth services in their routine patient care to lessen the risk of direct human-to-human exposure. Patients expressed concerns about personal visits to healthcare units and the possibility of accessing telemedicine turned out to be an effective tool for the continuity of care. Due to the limited experience with telemedicine before the COVID-19 pandemic in Poland, we sought to fill this gap by studying the experiences of Polish patients. Our study aimed to understand how patients define satisfaction and dissatisfaction with telemedicine during the COVID-19 pandemic in primary care. Twenty semi-structured interviews with primary care patients in the Podlaskie Voivodeship, Poland were conducted to understand satisfaction with telemedicine. Interview transcripts were analyzed using qualitative content analysis. The qualitative content analysis process involved familiarizing ourselves with the data, extracting text regarding satisfaction and dissatisfaction with the teleconsultation, condensing it into meaningful units assigning codes to them, and organizing codes into subcategories and categories. The entire analysis process was done through reflection and discussion until a consensus was reached between the researchers. From the participants' perspective, satisfaction with telemedicine was associated with receiving enough space to express their concerns. It was reported that they trusted their primary care physicians and felt comfortable during telemedicine consultations. Participants noted that connecting with a known, trusted doctor was more important than having a face-to-face visit with an unfamiliar physician. In our study, the participants equated satisfaction with treatment effectiveness. It was emphasized that in the event of unknown or unstable conditions, patients would prefer to be seen in person and receive a physical examination. In our research telemedicine met with a positive reception and was recognized by the majority of patients who made use of it as a valuable channel of contact with a primary care physician. In order to increase the level of patient satisfaction, the focus should be on improving aspects such as physician engagement and showing empathy during telemedicine, as well as providing complete, exhaustive information on the treatment process. Respecting patient needs and preferences during performing telemedicine visits is the goal of patient-centered care.

Sexual Health Assessment in Women with Lung Cancer study: Sexual health assessment in women with lung cancer.

Sexual health is understudied and underreported in patients with lung cancer, and most data precede the approval of widely used targeted therapies and immune checkpoint inhibitors. The authors sought to evaluate the prevalence of sexual dysfunction in women with lung cancer in our current clinical environment. This cross-sectional survey study was administered online to 249 women via the GO2 for Lung Cancer (GO2) Registry, using the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction Measures questionnaire. Participants were recruited between June 2020 to June 2021. Eligibility criteria included age >18years, self-identifying as a woman, fluency in English, and a lung cancer diagnosis within 10 years. Most (67%) had stage IV lung cancer and 47% were receiving targeted therapy; 66% were undergoing active treatment. Despite 54% of participants reporting "recent" sexual activity, most (77%) indicated having little to no interest in sexual activity and 48% reported recent minimal satisfaction with their sex life. The most common reasons negatively affecting participants' satisfaction with their sex life included fatigue (40%) and feeling sad/unhappy (28%). Common reasons for lack of recent sexual activity included lack of interest (68%) and vaginal dryness or pain (30%). Compared to pre-diagnosis, women were significantly less likely to have recent interest in sexual activity. In multivariable logistic-regression, vaginal dryness showed a significant negative association with recent interest in sexual activity. Sexual dysfunction is prevalent in women with lung cancer. Sexual health should be integrated into routine care for patients with lung cancer.